Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978704 | 12497870 | 4 | F | 200111 | 20160810 | 20160625 | 20160819 | EXP | GB-APOTEX-2016AP009315 | APOTEX | 54.00 | YR | M | Y | 0.00000 | 20160819 | CN | GB | GB |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124978704 | 12497870 | 1 | PS | PAROXETINE. | PAROXETINE | 1 | Oral | 40 MG, QD | 936.72699 | MG | N | 20031 | 40 | MG | TABLET | ||||
| 124978704 | 12497870 | 2 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Oral | UNK | N | 0 | TABLET | ||||||||
| 124978704 | 12497870 | 3 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | 30MG | N | 0 | 30 | MG | TABLET | ||||||
| 124978704 | 12497870 | 4 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | N | 0 | TABLET | ||||||||
| 124978704 | 12497870 | 5 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | N | 0 | TABLET | ||||||||
| 124978704 | 12497870 | 6 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | N | 0 | TABLET | ||||||||
| 124978704 | 12497870 | 7 | SS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | UNK | N | 0 | TABLET | ||||||||
| 124978704 | 12497870 | 8 | SS | STALEVO | CARBIDOPAENTACAPONELEVODOPA | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978704 | 12497870 | 9 | SS | MIRTAZAPINE. | MIRTAZAPINE | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978704 | 12497870 | 10 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 20 MG, UNK | U | U | 0 | 20 | MG | ||||||
| 124978704 | 12497870 | 11 | C | GAMANIL | 2 | Unknown | 70 MG, BID | U | U | 0 | 70 | MG | BID | ||||||
| 124978704 | 12497870 | 12 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978704 | 12497870 | 13 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978704 | 12497870 | 14 | C | SINEMET | CARBIDOPALEVODOPA | 1 | Unknown | UNK | U | U | 0 | ||||||||
| 124978704 | 12497870 | 15 | C | PROPRANOLOL | PROPRANOLOLPROPRANOLOL HYDROCHLORIDE | 1 | Unknown | 40 MG, TID | U | U | 0 | 40 | MG | TID | |||||
| 124978704 | 12497870 | 16 | C | AMITRIPTYLINE | AMITRIPTYLINE | 1 | Unknown | 10 MG, UNK | U | U | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124978704 | 12497870 | 1 | Depression |
| 124978704 | 12497870 | 2 | Depression |
| 124978704 | 12497870 | 8 | Parkinson's disease |
| 124978704 | 12497870 | 9 | Product used for unknown indication |
| 124978704 | 12497870 | 10 | Product used for unknown indication |
| 124978704 | 12497870 | 11 | Product used for unknown indication |
| 124978704 | 12497870 | 12 | Product used for unknown indication |
| 124978704 | 12497870 | 14 | Product used for unknown indication |
| 124978704 | 12497870 | 15 | Product used for unknown indication |
| 124978704 | 12497870 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124978704 | 12497870 | HO |
| 124978704 | 12497870 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124978704 | 12497870 | Abnormal dreams | |
| 124978704 | 12497870 | Aggression | |
| 124978704 | 12497870 | Agitation | |
| 124978704 | 12497870 | Anxiety disorder | |
| 124978704 | 12497870 | Apathy | |
| 124978704 | 12497870 | Decreased appetite | |
| 124978704 | 12497870 | Decreased interest | |
| 124978704 | 12497870 | Depression | |
| 124978704 | 12497870 | Feeling guilty | |
| 124978704 | 12497870 | Hallucination | |
| 124978704 | 12497870 | Hyperhidrosis | |
| 124978704 | 12497870 | Intrusive thoughts | |
| 124978704 | 12497870 | Muscle spasms | |
| 124978704 | 12497870 | Negative thoughts | |
| 124978704 | 12497870 | Nightmare | |
| 124978704 | 12497870 | Palpitations | |
| 124978704 | 12497870 | Panic attack | |
| 124978704 | 12497870 | Paraesthesia | |
| 124978704 | 12497870 | Parkinson's disease | |
| 124978704 | 12497870 | Psychomotor hyperactivity | |
| 124978704 | 12497870 | Restlessness | |
| 124978704 | 12497870 | Sleep disorder | |
| 124978704 | 12497870 | Suicidal ideation | |
| 124978704 | 12497870 | Tearfulness | |
| 124978704 | 12497870 | Terminal insomnia | |
| 124978704 | 12497870 | Tremor | |
| 124978704 | 12497870 | Trismus | |
| 124978704 | 12497870 | Weight decreased | |
| 124978704 | 12497870 | Withdrawal syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 124978704 | 12497870 | 1 | 20011017 | 20011211 | 0 | |
| 124978704 | 12497870 | 2 | 200007 | 20011217 | 0 | |
| 124978704 | 12497870 | 3 | 20011106 | 0 | ||
| 124978704 | 12497870 | 4 | 200007 | 0 | ||
| 124978704 | 12497870 | 5 | 20011211 | 20011217 | 0 | |
| 124978704 | 12497870 | 6 | 2001 | 0 | ||
| 124978704 | 12497870 | 7 | 20011129 | 0 | ||
| 124978704 | 12497870 | 9 | 200202 | 0 | ||
| 124978704 | 12497870 | 11 | 20011201 | 200201 | 0 | |
| 124978704 | 12497870 | 12 | 20011101 | 0 | ||
| 124978704 | 12497870 | 13 | 20011129 | 0 | ||
| 124978704 | 12497870 | 15 | 200007 | 0 | ||
| 124978704 | 12497870 | 16 | 200805 | 0 |